MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SHUNTASSISTANT 2.0 20; HYDROCEPHALUS MANAGEMENT

Model Number	FX642T
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a progav 2.0 shunt system (#fx642t) shoud be implanted on (b)(6) 2025.According to the complainant, the shunt system caused an underdrainge/blockage during surgery.Another shunt system was implanted.No patient complications were reported as a result of the procedure.The complained product was sent to the manufacturer for investigation.
Additional Manufacturer Narrative
Visual inspection during the investigation, no significant deformations or damage of the valve were determined.Permeability test a permeability test has shown that all components are permeable.During the permeability test bloody liquid were flushed out.Computer controlled test not necessary adjustment test the progav 2.0 was tested and is adjustable to all specified pressures.Braking force test the brake functionality test has shown that the brake function operates as expected.Internal inspection not possible due to the missing release.Results based on the investigation results, no functional deviations or other abnormalities of the progav 2.0 with the shuntassiatnt 2.0 were determined.The shunt operated within all specifications.Disassembly is not necessary because the valve was not implanted and no functional deviation was detected.The examination of the return has been completed with the drafting of this report actions no further actions are required as a result of the complaint.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.

• Brand Name: PROGAV 2.0 WITH SHUNTASSISTANT 2.0 20
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 23631283
• Report Number: 3004721439-2025-00359
• Device Sequence Number: 9381522
• Product Code: JXG
• UDI-Device Identifier: 04041906502003
• UDI-Public: (01)04041906502003(11)250218(17)300217(10)20080759
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FX642T
• Device Catalogue Number: FX642T
• Device Lot Number: 20080759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 77 KG